Trump derides ‘slow and burdensome’ approval process at FDA

ASHINGTON — President Trump on Tuesday called on the Food and Drug Administration to speed the approval of drugs to treat life-threatening diseases, deriding the agency’s current process as “slow and burdensome.”

In an address to a joint session of Congress, Trump said that the FDA approval process “keeps too many advances … from reaching those in need.”

He noted that his speech was taking place on Rare Disease Day and cited the case of Megan Crowley, who was diagnosed with Pompe disease, a rare condition that leads to muscle and respiratory damage, and who was among the first lady’s guests during the joint session of Congress.

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“Megan’s dad, John, fought with everything he had to save the life of his precious child,” Trump said. “He founded a company to look for a cure, and helped develop the drug that saved Megan’s life. Today she is 20 years old — and a sophomore at Notre Dame.”

“If we slash the restraints, not just at the FDA but across our government, then we will be blessed with far more miracles like Megan,” Trump said.

Throughout the presidential campaign, Trump called for the elimination of regulations and faster drug approvals. But he has not described how precisely he would speed those approvals and has not yet nominated a commissioner to head the FDA.

The two top candidates mentioned by his transition team are Dr. Scott Gottlieb, a former FDA deputy commissioner, and Jim O’Neill, a Silicon Valley protégé of billionaire Peter Thiel. Gottlieb has received bipartisan support, while O’Neill has met derision with his past comments that FDA need only determine if drugs are safe, not whether they actually work.

While promising to overhaul the Affordable Care Act, Trump on Tuesday pointed to the “unnecessary costs that drive up the price of insurance” and pledged to pursue reforms to do reduce them — including those aimed at drug costs.

Trump said he would “work to bring down the artificially high price of drugs and bring them down immediately.”

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The president has harshly criticized the drug industry in the last year and at times supported policies drug makers loathe, such as allowing Medicare to more directly negotiate the prices it pays for prescription drugs. Since meeting with industry leaders earlier this month, however, Trump has spoke more about the need to speed drug approvals.

Approving Cempra’s solithromycin (an antibiotic) without requiring the extra financially burdensome safety studies the FDA asked for in December (the company just laid off about 67% of their personnel due to this unexpected demand) could be one of the very first “quick wins” that the Trump administration can rapidly accomplish.

For more info, see: “Cempra’s Solithromycin And The Great FDA Echo Chamber”, on Seeking Alpha. (An account is needed past the first page.)